Method for a wireless data communication between a sensor system and a receiver, and a system for a wireless data communication

ABSTRACT

The disclosure relates to a method and a system for a wireless data communication between a sensor system and a receiver capable of receiving analyte values sensed by the sensor system in a continuous analyte monitoring. The method includes establishing an unconnected mode operation for the system. The receiver receives a first data package broadcasted by the sensor system that has first status data indicative of a device status and/or an analyte value status. The first status data is processed by a receiver controller. A connected mode operation is established for the system responsive to determining at least one of a critical device status and a critical analyte value status. The establishing includes establishing a communication channel between the sensor system and the receiver and receiving a second data package transmitted by the sensor system in the receiver, the second data package comprising one or more analyte values.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/229,413, filed Dec. 21, 2018, which is a continuation ofPCT/EP2017/064959, filed Jun. 19, 2017, which claims priority to EP 16175 960.0, filed Jun. 23, 2016, all of which are hereby incorporatedherein by reference in their entirety.

BACKGROUND

The present disclosure refers to a method for a wireless datacommunication between a sensor system and a receiver, a system for awireless data communication, and a computer program product.

Glucose monitoring helps people with diabetes manage the disease andavoid its associated problems. A person can use the results of glucosemonitoring to make decisions about food, physical activity, andmedications. A common way to check glucose level is performingdiscontinuous monitoring. Such checking usually involves pricking afingertip with an automatic lancing device to obtain a blood sample andthen using a glucose meter to measure the blood sample's glucose level.Such monitoring may also be referred to as spot monitoring.

As an alternative or in addition, continuous glucose monitoring (CGM)may be applied. A system for CGM may use a body sensor inserted underthe skin to check glucose levels. The sensor stays in place for severaldays to weeks or even longer and then must be replaced. A transmittersends information about an analyte value or level indicative of theglucose level via wireless and/or wired data transmission from thesensor to a receiver such as monitor device.

WO 2015/094981 A1 discloses a method for prolonging life of a batteryinstalled in an analyte sensor system. The method includes measuring afirst analyte value at a first time and causing a transmission of themeasured first analyte value along with a predicted second analytevalue. Measure a second analyte value at a second time and determinewhether a difference between the measured second analyte value and thepredicted second analyte value is within a predefined range. Skiptransmission of the measured second analyte value if the difference iswithin the predefined range.

U.S. Publication No. 2009/0118592 A1 discloses a medical systemcomprising a sensor unit and a receiving unit. The sensor unit isadapted to generate sensor data indicative of a time-dependentcharacteristic of a subject, and transmit data to a receiver atintervals determined by an analysis of time-dependent changes in thegenerated sensor data. The receiving unit is adapted to receive sensordata at a non-predetermined rate. It is proposed to skip thetransmission of sensor data in case there is no or only a small changein an actual sensor data value. On the other hand, in case of rapidchanges in sensor data values, sensor data may be transmitted at higherrate.

EP 2 011 283 B1 discloses a method for wireless transmission of databetween components of a blood glucose system by initially setting thereceiver activation frequency to a first frequency value upon switchingfrom communication mode to power saving mode, and setting the receiveractivation frequency to a second frequency value smaller than the firstfrequency value if no communication initiation data frame is receivedfor a predetermined power saving timeout period.

U.S. Pat. No. 8,622,903 B2 discloses a monitoring system with atransmitter configured to transmit once every minute randomly in awindow of time of plus or minus 5 seconds, i.e., in time hops. Forconserving power the receiver does not listen for its associatedtransmitter during the entire 10 second receive window, but only at thepredetermined time it knows the data package will be coming from thecorresponding transmitter.

WO 2015/069797 A1 discloses a method for a wireless data communicationbetween an analyte sensor system and a mobile device capable ofwirelessly receiving analyte values from the analyte sensor system. Themethod comprises transmitting a first series of advertisement signalsbeginning at a first time; receiving a data connection request from amobile device at a second time; establishing a data connection with themobile device; transmitting a connection interval indicative of adifference between the second time and the first time to the mobiledevice; transmitting an analyte value; terminating the data connectionwith the mobile device; and causing a transceiver of the analyte sensorsystem to enter a sleep state. A first analyte value measured at a firsttime is transmitted with a predicted second analyte value, and it isdetermined whether a difference between the measured second analytevalue and the predicted second analyte value is within a predefinedrange.

EP 2 973 082 A2 discloses a method for transmitting data between devicesof an analyte monitoring system, the method comprises the steps:generating sensor data using a sensor electronics module electricallyconnected to a continuous analyte sensor; establishing a two-waycommunication channel between the sensor electronics module and the adisplay device and each of the sensor electronics module and displaydevice transmitting at a first transmission power; and initiating a lowpower transmission mode responsive to sensing User input at Userinterface of the display device indicative of entering the mode, whereinthe low power transmission mode comprises one or both of the sensorelectronics module and the display device transmitting at a secondtransmission power that is lower than the first transmission power.

U.S. Publication No. 2015/0164391 A1 as cited in the extended Europeansearch report discloses an analyte sensor system configured to be wornby a user, comprising an analyte sensor, a transceiver configured totransmit and receive wireless signals, a battery, and a control modulecoupled to the transceiver and configured to determine that a remainingpower level of the battery is below a predefined power level, and causea change in one or more data transmission operations of the analytesensor system.

SUMMARY

The present disclosure provides a method for a wireless datacommunication between a sensor system and a receiver, and a system for awireless data communication for which the operation of collectinganalyte data is improved. Specifically, energy or power consumption isreduced in the disclosed arrangement provided with the receiver and thesensor system.

According to an aspect of the present disclosure, a method for awireless data communication between a sensor system and a receiver isprovided. The receiver is capable of wirelessly receiving, from thesensor system, analyte values sensed by the sensor system in acontinuous analyte monitoring. The method comprises establishing anunconnected mode operation for the sensor system and the receiver, andreceiving, by the receiver, a first data package broadcasted by thesensor system. The first data package comprises first status dataindicative of at least one of a device status and an analyte valuestatus. The first status data are processed by a receiver controller. Aconnected mode operation is established for the sensor system and thereceiver responsive to determining at least one of a critical devicestatus and a critical analyte value status in the processing. Theestablishing is comprising establishing a communication channel betweenthe sensor system and the receiver; and receiving, through thecommunication channel, a second data package transmitted by the sensorsystem to the receiver, the second data package comprising one or moreanalyte values.

According to another aspect, a system for wireless data communication,the system comprising a sensor system and a receiver is provided. Thereceiver is capable of wirelessly receiving, from the sensor system,analyte values sensed by the sensor system in a continuous analytemonitoring. The system is configured to establish an unconnected modeoperation for the sensor system and the receiver; receive, by thereceiver, a first data package broadcasted by the sensor system, thefirst data package comprising first status data indicative of at leastone of a device status and an analyte value status; process the statusdata by a receiver controller; and establish a connected mode operationfor the sensor system, and the receiver responsive to determining atleast one of a critical device status and a critical analyte valuestatus in the processing. The establishing is comprising establishing acommunication channel between the sensor system, and the receiver; andreceiving, through the communication channel, a second data packagetransmitted by the sensor system to the receiver, the second datapackage comprising one or more analyte values.

According to a further aspect, a computer program product is provided.

The connected mode may be established in response to user confirmationto be received in the receiver through a user input device. For example,in response to the determining of at least one of the critical devicestatus and the critical analyte status a request for a user input may beoutputted through a user interface of the receiver, e.g., a displaywhich may be connected to the receiver controller. After receiving theuser input provided in response to the user request output the connectedmode operation is established. Thereby, user confirmation may berequested prior to establishing or re-establishing the communicationchannel provided in the connected mode.

Sending and/or receiving of the data packages may be handled by atransceiver in at least one of the receiver and the sensor system.

The receiver may be a mobile or portable receiver. The receiver may beprovided in a mobile or portable device such as a handheld device, alaptop, a mobile phone, and a remote controller. The remote controllermay be configured to control operation of a medical system such as adrug delivery medical system. As an alternative, the receiver may beprovided in a none-mobile device such as a desktop computer.

The sensor which may also be referred to as analyte sensor or biosensormay be configured for monitoring an analyte in a bodily fluid. Forexample, a glucose value of a bodily fluid may be monitored. However,the technologies disclosed may be used with regard to other analytes aswell.

The first data package may be free of any analyte value. In conclusion,in such alternative embodiment neither the status data nor the firstdata package as whole includes any actual analyte value.

In an embodiment, the broadcasting of data packages by the sensor may bedistinguished from transmitting or sending data packages from the sensorsystem to the receiver through the communication channel. In thebroadcasting the data packages may be sent out to any device located inan area covered by the sensor device and capable of receiving such datapackages by wireless transmission. Differently, the data packagestransmitted by the sensor system through the communication channel aredirected to be received by the receiver to which the sensor system hasbeen paired in a device pairing process before.

The data processing, by the receiver controller, aims at determiningwhether the status data are indicating at least one of a critical devicestatus and a critical analyte status. With regard to the critical devicestatus, a critical device status selected from the following group maybe determined by the data processing: sensor session stopped; powersupply (battery) low; sensor type incorrect for the sensor system;sensor malfunction; device alert; occurrence of device fault in thesensor system; and request for time synchronization between the sensorsystem and the receiver. As an alternative or in addition, the criticaldevice status may indicate at least one of the following: sensorcalibration not allowed; sensor calibration recommended; and sensorcalibration required. The status data may be indicative of a sensortemperature being outside a sensor temperature range required forvalidly sensing analyte values.

With regard to the critical analyte value status, the status data may beindicative of an alert message. The alert message may be generated bythe sensor controller in response to detecting at least one criticalanalyte value status from the following group: analyte value lower thana patient specific low analyte level; analyte value higher than apatient specific high analyte level; analyte value lower than a hypolevel (hypoglycaemia); analyte value higher than a hyper level(hyperglycaemia); a rate of analyte value decrease is exceeding a limit;a rate of analyte value increase is exceeding a limit; analyte valuelower than a sensitivity of the sensor system; and analyte value higherthan a sensor limit.

The method may further comprise operating the receiver on a first powerconsumption level in the unconnected mode operation; and operating thereceiver on a second power consumption level in the connected modeoperation, the second power consumption level being higher than thefirst power consumption level. Operating the arrangement comprising thesensor system and the receiver on the different power consumption levelswill save energy, thereby, extending the lifetime of the power supplysuch as a battery.

The method may further comprise establishing a sleeping mode operationfor a functional unit of the receiver in the unconnected mode operation;and establishing an activated mode operation for the functional unit inthe connected mode operation, wherein a power consumption level of thefunctional unit is higher in the activated mode operation compared tothe sleeping mode operation.

The receiving of the first data package may comprise receiving, by thereceiver, an unencrypted data package broadcasted by the sensor system,the unencrypted data package comprising the status data. The first datapackage as whole may be broadcasted and received without dataencryption.

The method may further comprise establishing a secure communicationchannel between the sensor system, and the receiver, the securecommunication channel being capable of communicating encrypted datapackages; and receiving, through the secure communication channel, anencrypted data package included in the second data package, theencrypted data package comprising the one or more analyte values. Thesecure communication channel may be established or set-up in the devicepairing process described in further detail below. The establishing orsetting-up of the secure communication channel configured for secure andencrypted data transmission may comprise exchanging keys for secure dataexchange (secure keys) between the two devices.

The establishing of the communication channel may comprise establishinga bidirectional communication channel between the sensor system and thereceiver. The bidirectional communication channel will allow for sendingand receiving data packages on both the receiver side and the sensorsystem side.

The method may further comprise maintaining the unconnected modeoperation for the sensor system, and the receiver responsive to notdetermining both the critical device status and the critical analytevalue status in the processing; and receiving a third data packagebroadcasted by the sensor system in the receiver, the third data packagecomprising further status data indicative of at least one of a presentdevice status and a present analyte status. Neither the critical devicestatus nor the critical analyte status is determined in the processingof the first status data. The receiver does not recognize need forestablishing or re-establishing the communication channel between thesensor system and the receiver.

The method may further comprise providing device specific status data inthe first data package; determining, by the receiver controller, whetherthe receiver controller is capable of processing the device specificstatus data; and processing the device specific status data by thereceiver controller, if it is determined that the receiver controller iscapable of processing the device specific status data, otherwiseignoring the device specific status data in the receiver. For example, areceiver from a device supplier may not be capable of correctlyprocessing device specific data from a sensor system provided by adifferent device supplier because of a non-standard data exchangeprotocol. Still, in response to the ignoring the status data theconnected mode of operation may be established. Thereby, thetransmission of the one or more analyte value to the receiver may beperformed without having determined at least one of a critical devicestatus and a critical analyte value status. It shall avoid a criticalsituation just because of failing to process the status data in thereceiver. A higher level of safety may be reached. Loss of criticalstatus data can be avoided.

The status data may be provided by a status flag or a status data field.In such embodiment or in other embodiments the status data may compriseone or more codes, e.g., alphanumeric codes, to which is assigned atleast one of the critical analyte value status and the critical devicestatus. In the receiver assignment between the one or more codes and thecritical status is provided which allows the receiver controller todetermine the critical status from processing the status data comprisingthe one or more codes. Such code may be provided in the status flag orthe status data field. In response to determining the status flag or thestatus data field in the receiver, a user warning may be output by thereceiver, the user warning may comprise output of at least one of videodata and sound data.

The establishing of the connected mode operation may further compriseperforming a device pairing process for the sensor system, and thereceiver responsive to determining at least one of the critical devicestatus and the critical analyte value status in the processing. Thedevice pairing process may comprise establishing a secure and encryptedconnection for data transmission between the receiver and the sensorsystem. The establishing or setting-up of the connection (communicationchannel) configured for secure and encrypted data transmission maycomprise exchanging keys for secure data exchange (secure keys) betweenthe two devices.

After the initial device pairing has been completed, reconnection may bedone without repeating device pairing or key exchange. Reconnectingcomprises establishing the communication channel between the sensorsystem and the receiver again after the connection was interrupted orstopped, for example, during the time period between successive eventsof data transmission defined by time intervals. Following, after there-establishing of the connection between the devices analyte valuesdetected by the sensor may be received in the receiver. In anembodiment, control signals may be transmitted from the receiver to thesensor system, the control signals defining a time delay between the endof the device connection process which is establishing the communicationchannel and the starting point of transmitting the one or more analytevalues to the receiver. As an alternative, the time period can bedetermined in relation to the point in time at which a formertransmission of one or more analyte values was started.

The method may further comprise receiving, by the receiver, a fourthdata package broadcasted by the sensor system, the fourth data packagecomprising second status data indicative of at least one of the devicestatus and the analyte value status; processing the second status databy the receiver controller; and re-establishing the connected modeoperation for the sensor system and the receiver responsive todetermining at least one of the critical device status and the criticalanalyte value status in the processing, the re-establishing comprisingre-establishing the communication channel between the sensor system andthe receiver; and receiving, through the communication channel, a fifthdata package transmitted by the sensor system in the receiver, the fifthdata package comprising one or more further analyte values. Once thedevice pairing has been performed for the sensor system and thereceiver, the communication channel may be re-established withoutpairing the devices again.

With regard to a glucose measurement or monitoring, a glucose level orvalue may be determined by analyzing a blood sample via, e.g., spotmonitoring, and, as an alternative or in addition, by continuous glucosemonitoring (CGM) via a fully or partially implanted sensor. In general,in the context of CGM an analyte value or level indicative of a glucosevalue or level in the blood may be determined. The analyte value may bemeasured in an interstitial fluid. The measurement may be performedsubcutaneously or in vivo. CGM may be implemented as a nearly real-timeor quasi-continuous monitoring procedure frequently or automaticallyproviding/updating analyte values without user interaction. In analternative embodiment, analyte may be measured with a biosensor in acontact lens through the eye fluid or with a biosensor on the skin viatransdermal measurement in sudor.

The alternative embodiments described above may apply to the system fora wireless data communication or transmission mutatis mutandis.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned aspects of exemplary embodiments will become moreapparent and will be better understood by reference to the followingdescription of the embodiments taken in conjunction with theaccompanying drawings, wherein:

FIG. 1 is a schematic representation of elements of a continuous analytemonitoring system comprising a sensor system and a receiver; and

FIG. 2 is a schematic representation with regard to a method forwireless data communication between the sensor system and the receivercapable of wirelessly receiving, from the sensor system, analyte valuessensed by the sensor system in a continuous analyte monitoring.

DESCRIPTION

The embodiments described below are not intended to be exhaustive or tolimit the invention to the precise forms disclosed in the followingdescription. Rather, the embodiments are chosen and described so thatothers skilled in the art may appreciate and understand the principlesand practices of this disclosure.

FIG. 1 shows schematic representation illustrating elements ofembodiments of a continuous analyte monitoring system 10 comprising asensor system 20 and a receiver 30.

The analyte sensor system 20 may include a sensor 21 which may beprovided as analyte sensor or biosensor. The sensor 21 is capable ofsensing analyte values for an analyte in a fluid such as a bodily fluid.The sensor 21 is coupled to a sensor measurement circuit 22 providingfor, e.g., processing and managing sensor data. The sensor measurementcircuit 22 may be coupled to a sensor controller 23 comprising one ormore processors. In some embodiments, the sensor controller 23 mayperform part or all of the functions of the sensor measurement circuit22 for obtaining and processing sensor measurement values (analytevalues) from the sensor 21.

The sensor controller 23 is further coupled to a data interface 24 forsending sensor data. The data interface 24 may be provided with atransceiver configured to send and receive data through a communicationchannel 40. The data interface 24 which may be capable of receivingrequests and commands from an external device, such as the receiver 30,which, for example, is used to receive data packages from the sensorsystem 20 through wireless data transmission.

According to the exemplary embodiment, the sensor system 20 furtherincludes a memory 25 for storing data, e.g., sensor data indicative ofthe analyte values. The memory 25 may also be used for storing anoperating system for a custom application designed for wireless datacommunication between the sensor system 20 and the receiver 30. Thememory 25 may be a single memory device or multiple memory devices andmay be a volatile or non-volatile memory for storing data and/orinstructions for software programs and applications. The instructionsmay be executed by the processor(s) of the sensor controller 23 tocontrol and manage the data interface 24.

Components of the sensor system 20 may require replacement periodically.For example, as shown in FIG. 1 , the sensor 21 may be provided in thesensor system 20 that includes the sensor measurement circuit 22, thesensor controller 23, the data interface 24, the memory 25, e.g., atransceiver, and a power supply 26 such as a battery. The sensor 21 maybe an implantable sensor.

The sensor 21 may require periodic replacement, e.g., every 7 to 30days. The sensor measurement circuit 22 may be configured to be poweredand active for much longer than the sensor 21, e.g., for three, sixmonths or more, until the battery needs replacement. Replacing thesecomponents may be difficult and require the assistance of trainedpersonnel. Reducing the need to replace such components, particularlythe battery, significantly improves the convenience of the sensor system20 to the user.

Still referring to FIG. 1 , the receiver 30 may include a display 31 foroutputting video information to a user. The display 31 is coupled to areceiver controller 32 providing for, e.g., processing and managingdata. The receiver controller 32 may comprise one or more processors.Further, the receiver 30 may be provided with a memory 33 coupled to thereceiver controller 32. The receiver controller 32 is further coupled toa data interface 34 for receiving data packages from the sensor system20 through the communication channel 40. The data interface 34 may becapable of receiving requests and commands from an external device, andof sensing data through wireless data transmission, for example, to thesensor device 20.

According to the embodiment in FIG. 1 , the receiver 30 has a user inputdevice 35 connected to the receiver controller 32. User input may bereceived through the user input device 35.

The receiver 30 may be provided in a mobile or portable device such assmartphone, mobile phone, laptop computer, hand-held computing device orpersonal digital assistant.

In some embodiments, a sensor session may correspond to the life of thesensor 21, e.g., in the range of 7 to 30 days. When the sensor system 20is used for the first time or re-activated once a battery has beenreplaced in some cases, a sensor session may be established. There maybe a process for initially establishing communication between thereceiver 30 and the sensor system 20 when it is first used orre-activated (e.g., the battery is replaced). Such initial process maycomprise a device pairing process.

In case of a first or initial device connecting and prior to actuallyreceiving one or more analyte values in the receiver 30, a so-calleddevice pairing process is provided between the receiver 30 and thesensor system 20. In general, the device pairing process is the initialprocess for establishing the connection for data transmission betweenthe receiver 30 and the sensor system 20. By the pairing process aunidirectional or bidirectional data transmission line or connection isestablished between the devices. In response to finalizing the devicepairing which is known as such, e.g., with regard to pairing Bluetoothdevices, through the communication channel 40, the one or more analytevalues may be transmitted immediately or in a timely delayed fashionfrom the sensor system 20 to the receiver 30.

Prior to the device pairing process, the sensor system 20 may bycontinuously broadcasting a signal “ready for pairing.” Such signalindicates that the sensor system 20 may be paired with some other devicefor transmitting data. In response to detecting the signal “ready forpairing,” the receiver 30 may start the pairing process for establishingthe connection for data transmission between the receiver 30 and thesensor system 20.

Once the receiver 30 and the sensor system 20 have establishedcommunication, specifically by establishing the communication channel40, the receiver 30 and the sensor system 20 may periodically ornon-periodically be in communication over the life of several sensorsuntil, for example, the battery needs to be replaced. Each time thesensor 21 is replaced, a new sensor session may be established. The newsensor session may be initiated through a process completed using thereceiver 30 and the process may be triggered by notifications of a newsensor via the communication between the sensor system 20 and thereceiver system 30 that may be persistent across sensor sessions.

After completion of the pairing process, the communication channel maybe interrupted, e.g., because of missing need for data transmissionbetween the sensor system 20 and the receiver 30. For re-establishingthe communication channel 40 there may be no need for device pairingagain. Rather, the communication channel 40 may be established betweenthe sensor system 20 and the receiver 30 without repeating devicepairing. Once the communication channel is interrupted the sensor systemmay continuously broadcast a signal “ready for connecting/establishingthe communication channel.” Such signal indicates that the sensor system20 may be connected to the receiver 30 for transmitting data again. Inresponse to detecting the signal which may be broadcasted as anunencrypted signal, the receiver 30 may start the connecting process,thereby re-establishing the communication channel 40.

Wireless communication protocols may be used to transmit and receivedata between the sensor system 20 and the receiver 30. The wirelessprotocol used may be designed for use in a wireless sensor network thatis optimized for periodic or aperiodic and small data transmissions toand from multiple devices in a close range, e.g., a personal areanetwork (PAN). For example, the protocol may be optimized for periodicor aperiodic data transfers where transceiver units may be configured totransmit data for short intervals and then enter low power modes forlong intervals.

The wireless communication protocol may further be configured toestablish communication channels with multiple devices whileimplementing interference avoidance schemes. In some embodiments, theprotocol may make use of adaptive isochronous network topologies thatdefine various time slots and frequency bands for communication withseveral devices. The protocol may thus modify transmission windows andfrequencies in response to interference and to support communicationwith multiple devices. Accordingly, the wireless protocol may use timeand frequency division multiplexing (TDMA) based schemes. The wirelessprotocol may also employ direct sequence spread spectrum (DSSS) andfrequency-hopping spread spectrum schemes. Various network topologiesmay be used to support short-distance and/or low-power wirelesscommunication such as peer-to-peer, start, tree, or mesh networktopologies such as WiFi, Bluetooth and Bluetooth Low Energy (BLE). Thewireless protocol may operate in various frequency bands such as an openISM band such as 2.4 GHz.

In some embodiments, when a standardized communication protocol is used,commercially available transceiver circuits or units may be utilizedthat incorporate processing circuitry to handle low level datacommunication functions such as the management of data encoding,transmission frequencies, handshake protocols, and the like. In theseembodiments, the receiver controller 32/the sensor controller 23 doesnot need to manage these activities, but rather provides desired datavalues for transmission, and manages high level functions such as powerup or down, set a rate at which messages are transmitted, and the like.Instructions and data values for performing these high level functionscan be provided to the transceiver circuits via a data bus and transferprotocol established by the manufacturer of the transceiver circuit.

The sensor system 20 gathers analyte values detected by from the sensor21 that it may send to the receiver 30 in a periodical or aperiodicfashion. Data points are gathered and transmitted over the life of thesensor 21, e.g., in the range of 1 to 30 days or more. New measurementsmay need to be transmitted often enough to adequately monitor glucoselevels in a bodily fluid. Rather than having the transmission andreceiving elements of both the sensor system 20 and the receiver 30continuously communicating, the sensor system 20 and the receiver 30 mayestablish the communication channel 40 between them based on periodic orsporadic need requirements.

Referring still to FIG. 1 , the exemplary system or arrangement depictedincludes the sensor system 20 communicatively coupled to the receiver 30through the data interfaces 24, 34 which, e.g., may be implemented witha transceiver unit. The coupling is provided for transmitting biologicalor analyte data indicative of properties of an analyte such as glucosefrom the sensor system 20 to the receiver 30. In case of usingtransceivers, the data interface 25 provides for a sensor-sidetransceiver. The sensor system 20 is provided with a sensor-sidetransceiver configured for transmitting and receiving electronic data.

The biological or analyte data received in the receiver 30 at least inpart may be stored in the memory 33. The sensor 21 may be provided asbody sensor at least in part implantable into a human body.

In one embodiment, the sensor 21 is a glucose sensor configured todetect or sense a glucose level (e.g., glucose concentration) whenplaced just under the skin of a patient. Specifically, a subcutaneouslyplaced sensor may be provided. For example, the sensor 21 can be adisposable glucose sensor that is worn under the skin for a few daysuntil replacement is needed. As is noted above, the sensor system 20 iscommunicatively coupled with the receiver 30. Accordingly, in the caseof a glucose sensor, the sensor system 20 can be communicatively coupledwith, for example, a hand held device such as a smart phone or a remotecontrolling device, or a smart glucose meter and can provide ambulatoryCGM data, i.e., glucose data that is sampled continuously throughout thelifetime of the sensor 21. The receiver 30 provided in such hand helddevice may control the data transmission from the sensor system 20 tothe handheld by initiating transmission of analyte values.

Referring to the schematic representation in FIG. 2 , an embodiment of amethod for wireless data communication between the sensor system 20 andthe receiver 30 capable of wirelessly receiving, from the sensor system20, analyte values sensed by the sensor 21 in a continuous analytemonitoring is described. The continuous analyte monitoring, for example,can be a continuous glucose monitoring.

In step 100 the receiver 30 and the sensor system 20 are provided.

In step 110 an unconnected mode operation is established for the sensorsystem 20 and the receiver 30. In the unconnected mode operation thecommunication channel 40 is interrupted. Rather, the receiver 30 islistening to signals or data packages broadcasted by the sensor system20. Such mode of operation may be referred to as listen mode operation.For example, the sensor system 20 may broadcast a so-calledadvertisement signal which indicates that the sensor system 20 is readyfor setting-up a connection for data transmission. Such process maycomprise a device pairing process which may in turn comprisesestablishing the communication channel 40.

In the unconnected mode operation the receiver 30 may receive signalsand/or data packages broadcasted by the sensor system 20 via the datainterface 34. In step 120 the receiver 30 is receiving a first datapackage comprising status data from the sensor system 20. The statusdata are indicative of at least one of a device status and an analytestatus. The device status provides information about the status of thesensor system 20 and/or the status of a component of the sensor system20 such as the sensor 21. The analyte status may refer to specificinformation about the analyte values sensed by the sensor 21. Forexample, in case of glucose level monitoring, a critical analyte valuestatus may indicate a hypo level (hypoglycaemia) or a hyper level(hyperglycaemia). The analyte status may be free of any informationabout an actual analyte value such as a glucose level value. The statusdata may be provided by a status flag or a data field within the firstdata package received in the receiver 30.

The first data package received in the receiver 30 is processed by thereceiver controller 32 in step 130. For example, the data processingaims at determining whether the status data are indicating at least oneof a critical device status and a critical analyte status. With regardto the critical device status, a critical device status selected fromthe following group may be determined by the data processing: sensorsession stopped; power supply (battery) low; sensor type incorrect forthe sensor system; sensor mail function; device alert; occurrence ofdevice fault in the sensor system; and request for time synchronizationbetween the sensor system and the receiver. As an alternative or inaddition, the critical device status may indicate one of the following:sensor calibration not allowed; sensor calibration recommended; and/orsensor calibration required. The status data may be indicative of asensor temperature being outside a sensor temperature range required forvalidly sensing analyte values.

With regard to the critical analyte value status, the status data may beindicative of an alert message. The alert message may be generated bythe sensor controller 23 in response to detecting at least one criticalanalyte value status from the following group: analyte value lower thana patient specific low analyte level; analyte value higher than apatient specific high analyte level; analyte value lower than a hypolevel (hypoglycaemia); analyte value higher than a hyper level(hyperglycaemia); a rate of analyte value decrease is exceeding a limit;a rate of analyte value increase is exceeding a limit; analyte valuelower than a sensitivity of the sensor system; and analyte value higherthan a sensor limit.

In step 140, in response to determining at least one of the criticaldevice status and the critical analyte value status a connected modeoperation is established for the sensor system 20 and the receiver 30.The establishing of the connected mode operation comprises establishingthe communication channel 40 between the sensor system 20 and thereceiver 30 in step 150.

Further, in step 160 a second data package from the sensor system 20 isreceived in the receiver 30. The second data package comprises one ormore analyte values sensed by the sensor 21 in the continuous analytemonitoring measurement. The second data package may be received as anencrypted data package in the receiver 30. Contrary, the first datapackage may be transmitted without encryption from the sensor system 20to the receiver 30.

The unconnected mode operation and the connected operation,respectively, require a different power consumption level in thereceiver 30 and/or the sensor system 20. For example, in the unconnectedmode operation at least one component of the receiver 30 such as theinput device 35 and/or the display 31 may be in a sleeping mode,thereby, having a reduced power or energy consumption. There may be evenno power consumption in the sleeping mode operation. In response toestablishing the connected mode operation, one or more functionalcomponents of the receiver 30 and/or the sensor system 20 may beswitched to a functional or activated mode operation from the sleepingmode operation, thereby, increasing the level of power consumption forsuch functional component(s) in the receiver 30 and/or the sensor system20, respectively, as whole.

Maintaining the system for wireless data transmission comprising thesensor system 20 and the receiver 30 in the unconnected mode operationwill save energy or power compared to the connected mode operation. Onlyif the status data indicate need for device connection (connected modeoperation) the unconnected mode operation is left for switching to theconnected mode operation.

The application of the unconnected and the connected mode operation asoutlined above may be applied to different use scenarios of the systemcomprising the sensor system 20 and the receiver 30. For example, theunconnected mode operation may be maintained overnight, the nighttimebeing a daytime for which the user may be not interested in receivinganalyte values from the sensor system 20. Still, the status datareceived in the receiver 30 will ensure that device connection, i.e.,establishing or re-establishing the communication channel 40, isautomatically initiated in case at least one of the critical devicestatus and the critical analyte value status is detected. In such case,a warning message may be outputted to the user, e.g., through thedisplay 31.

Another embodiment may refer to a time period in which the user may benot disturbed by receiving analyte values in the receiver 30, forexample, while visiting a theatre or a cinema. Again, the status datareceived in the receiver 30 will ensure that analyte values aretransmitted from the sensor system 20 to the receiver 30 if the criticaldevice status and/or the critical analyte value status are detected.

In the different embodiments described above, the unconnected modeoperation may be established in response to a user input. As an option,the user may define a predefined time period for the establishing of theunconnected mode operation, e.g., several hours. Only in case thecritical device status and/or the critical analyte value status isdetermined in the receiver 30 after receiving the first data packagecomprising the status data, the unconnected mode operation may bestopped for switching to the connected mode operation.

While exemplary embodiments have been disclosed hereinabove, the presentinvention is not limited to the disclosed embodiments. Instead, thisapplication is intended to cover any variations, uses, or adaptations ofthis disclosure using its general principles. Further, this applicationis intended to cover such departures from the present disclosure as comewithin known or customary practice in the art to which this inventionpertains and which fall within the limits of the appended claims.

What is claimed is:
 1. A receiver, comprising: a processor; a memory;and a data interface; wherein the receiver is configured to: wirelesslyreceive analyte values from a continuous analyte monitoring sensor;receive a first data package broadcasted by the continuous analytemonitoring sensor, the first data package having analyte value statusdata; process the analyte value status data; determine from theprocessed analyte value status data a critical analyte value status;establish a connected mode operation for the receiver and the continuousanalyte monitoring sensor; and receive a second data package transmittedby the continuous analyte monitoring sensor, the second data packagecomprising one or more analyte values.
 2. The receiver of claim 1,wherein the receiver is a drug delivery system controller.
 3. Thereceiver of claim 1, wherein the receiver is configured to run in afirst power consumption mode while running in an unconnected mode. 4.The receiver of claim 3, wherein the receiver is configured to run in asecond power consumption mode while running in the connected mode. 5.The receiver of claim 4, wherein the first power consumption mode islower than the second power consumption mode.
 6. The receiver of claim1, wherein the receiver is a smart phone.
 7. The receiver of claim 1,wherein a secure communication channel configured to communicateencrypted data packages between the continuous analyte monitoring sensorand the receiver is established for the connected mode operation.
 8. Thereceiver of claim 7, wherein the second data package is an encrypteddata package.
 9. A drug delivery system, comprising: a pump; and areceiver, comprising: a processor; a memory; and a data interface;wherein the receiver is configured to: wirelessly receive analyte valuessensed by a continuous analyte monitoring sensor; receive a first datapackage broadcasted by the continuous analyte monitoring sensor, thefirst data package having analyte value status data; process the analytevalue status data; determine from the processed analyte value statusdata a critical analyte value status; establish a connected modeoperation for the receiver and the continuous analyte monitoring sensor;and receive a second data package transmitted by the continuous analytemonitoring sensor, the second data package comprising one or moreanalyte values.
 10. The drug delivery system of claim 9, wherein thereceiver is configured to run in a first power consumption mode whilerunning in an unconnected mode.
 11. The drug delivery system of claim10, wherein the receiver is configured to run in a second powerconsumption mode while running in the connected mode.
 12. The drugdelivery system of claim 11, wherein the first power consumption mode islower than the second power consumption mode.